STP810

    Cytotoxicity Testing: Prediction of In Vivo Toxicity from In Vitro Tests

    Published: Jan 1983


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    Abstract

    Tissue culture laboratories can play key roles in the development and evaluation of products. Three broad categories of materials are evaluated: new product components (polymers, fabrics, and adhesives), candidate packaging materials (papers, plastics, coatings, and inks), and existing products undergoing stability studies. Material cytotoxicity is evaluated with mouse fibroblasts (L-929) using several standardized tests: agar overlay, elution assay, and direct growth assay. The severity of specimen testing is governed by the intended use of the material. Testing severity decreases in order of the following end use categories: implantations, limited patient contact, indirect patient contact, and no patient contact.

    Sample cytotoxicity is compared with that of standard, calibrated controls. Controls are formulated such that they evoke minimal responses in United States Pharmacopeia toxicity tests. Each lot of control material is certified via in vivo analysis before being used in cell culture. Control responses in vitro are then used to predict in vivo toxicity. Since the control is known to evoke a minimal in vivo response, its cell-culture response may be assumed to be equivalent to that of minimal in vivo toxicity. It is assumed that any material having a cell-culture response greater than the control will be toxic when tested in vivo. Studies are underway to further refine the correlation between in vivo and in vitro test methods.

    Keywords:

    tissue culture, cytotoxicity, in vivo toxicity


    Author Information:

    Genova, TF
    Section manager, assistant scientist, senior technician, research assistant, and manager of microbiology, ETHICON, Inc., Somerville, N. J.

    Bodnar, S
    Section manager, assistant scientist, senior technician, research assistant, and manager of microbiology, ETHICON, Inc., Somerville, N. J.

    Vaccarella, M
    Section manager, assistant scientist, senior technician, research assistant, and manager of microbiology, ETHICON, Inc., Somerville, N. J.

    Stafford, C
    Section manager, assistant scientist, senior technician, research assistant, and manager of microbiology, ETHICON, Inc., Somerville, N. J.

    Schady, KM
    Section manager, assistant scientist, senior technician, research assistant, and manager of microbiology, ETHICON, Inc., Somerville, N. J.


    Paper ID: STP30156S

    Committee/Subcommittee: F04.15

    DOI: 10.1520/STP30156S


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